MedPath

Computer Assisted Total Knee Replacement

Phase 4
Completed
Conditions
Total Knee Arthroplasty
Osteoarthritis
Registration Number
NCT00279838
Lead Sponsor
Mayo Clinic
Brief Summary

The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

Detailed Description

Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation.

Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation
Secondary Outcome Measures
NameTimeMethod
To compare the frontal alignment of the femoral and tibial components from full length standing radiographs
To compare sagittal alignment of the femoral and tibial components from lateral radiographs
To compare the rotation of the femoral and tibial components from CT Scan.

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Jacksonville, Florida, United States

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